About the SPIRIT III Trial
SPIRIT III is a prospective, multi-center, randomized, single-blind, controlled clinical trial comparing XIENCE V to TAXUS in 1,002 patients (669 XIENCE V patients, 333 TAXUS patients) with either one or two de novo native coronary artery lesions. The trial was conducted across 65 academic and community-based centers in the United States between June 22, 2005 and March 15, 2006.
The primary endpoint of the SPIRIT III trial was in-segment late loss at eight months, wherein XIENCE V demonstrated superiority to TAXUS with a statistically significant 50 percent reduction in late loss (mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS). In-segment late loss is a measure of vessel renarrowing. In the co-primary endpoint of TVF at nine months, XIENCE V demonstrated statistical non-inferiority compared to TAXUS with an observed 20 percent reduction in TVF (7.2 percent for XIENCE V vs. 9.0 percent for TAXUS).
Additionally, in the pre-specified secondary endpoint of MACE, XIENCE V demonstrated a 43 percent reduction at nine months (4.6 percent for XIENCE V vs. 8.1 percent for TAXUS) and a 42 percent reduction in MACE at one year (6.0 percent for XIENCE V vs. 10.3 percent for TAXUS) compared to TAXUS.
About XIENCE V
The XIENCE V stent system utilizes everolimus, which has been shown to reduce tissue proliferation in the coronary vessels following stent implantation, and is based upon the highly deliverable and proven MULTI-LINK VISION(R) coronary stent platform.
XIENCE V was launched in Europe and other international markets in October 2006. XIENCE V is currently an investigational device in the United States and Japan, and is under review for approval by the FDA. Abbott expects to gain FDA approval for XIENCE V in the second quarter of 2008.
Abbott also supplies a private-label version of XIENCE
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